Systems and methods for mounting and using a surgical stay on an end effector

Abstract

A stretcher device (10) includes an applicator assembly (14), the applicator assembly (14) including an applicator body (22) and a release liner (24), the applicator body (22) being flexible, the release liner (24) including a sacrificial sheet (30). The release liner (24) is coupled to the applicator body (22). The stretcher device (10) includes a stretcher (12) positioned on the applicator body (22) and includes a stretcher fastener (26) configured to couple the stretcher (12) to an end effector (16). The stretcher fastener (26) is configured to releasably fasten to the release liner (24). The support plate device (10) has a first configuration and a second configuration, wherein in the first configuration, the support plate (12) is coupled to the applicator assembly (14), and in the second configuration, the support plate (12) is separated from the applicator assembly (14), wherein in the second configuration, the sacrificial sheet (30) is removed from the applicator assembly (14).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 181,711 filed on April 29, 2021, which is incorporated herein by reference in its entirety. Technical Field

[0003] Embodiments of the present invention generally relate to surgical stay technology, and more particularly, to systems and methods for mounting a surgical stay on an end effector and using the surgical stay during a surgical procedure. Summary of the invention

[0004] In one embodiment, a stretcher device includes an applicator assembly, the applicator assembly including an applicator body and a release liner, wherein the applicator body is flexible and the release liner includes a sacrificial sheet. The release liner is coupled to the applicator body. The stretcher device also includes: a stretcher positioned on the applicator body; and a stretcher fastener, the stretcher fastener configured to couple the stretcher to an end effector. The stretcher fastener is configured to releasably fasten to the release liner. The stretcher device has a first configuration and a second configuration, wherein in the first configuration, the stretcher is coupled to the applicator assembly, and in the second configuration, the stretcher is separated from the applicator assembly, wherein in the second configuration, the sacrificial sheet is removed from the applicator assembly.

[0005] In one embodiment, a surgical stapling system includes a spreader device and a surgical stapler including an end effector having a first jaw and a second jaw. The spreader device can be inserted through the first jaw and the second jaw.

[0006] In one embodiment, a method of assembling a riser device includes positioning a riser on an applicator body and positioning a release liner on the riser to adhere a riser fastener to the riser. The release liner is coupled to the applicator body.

[0007] In one embodiment, a method of applying a stretcher to an end effector includes mounting a stretcher device on the end effector, removing a sacrificial sheet from an applicator assembly to expose a stretcher fastener, and manipulating the applicator body to adhere the stretcher fastener to the end effector.

[0008] In one embodiment, a method for suturing a patient's anatomical structure during minimally invasive surgery includes providing an end effector, the end effector including: a first jaw having a first end, a second end, a longitudinal axis, and an anvil, wherein the anvil includes an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a staple cartridge holding a plurality of staples, the staple cartridge having a staple cartridge face, wherein the first end of the first jaw is coupled to the first end of the second jaw; and a stay, the stay including a detachable portion and a remainder, wherein the detachable portion and the remainder are removably coupled by a perforated band, and the remainder is coupled to the first jaw or the second jaw for the duration of the minimally invasive surgery. The method may also include: inserting the end effector through a trocar to access the anatomical structure, positioning the staple cartridge face on a first side of the anatomical structure, positioning the anvil face on a second side of the anatomical structure, clamping the end effector on the anatomical structure, operating the end effector to cause the plurality of staples from the staple cartridge to suturing the anatomical structure, and opening the end effector to tear the perforated band. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present invention will be more easily understood through the detailed description of some exemplary embodiments in conjunction with the following drawings:

[0010] Figure 1 is a top view of a brace assembly according to an exemplary embodiment.

[0011] Figure 2 yes Figure 1 Exploded view of the support plate device.

[0012] Figure 3 is a top view of a riser member having discrete segments along its length according to an exemplary embodiment.

[0013] Figure 4 is a top view of a riser member having a distal slit according to an exemplary embodiment.

[0014] Figure 5 yes Figure 1 A perspective view of a support plate device, wherein the support plate assembly is mounted on the end effector.

[0015] Figure 6 is connected to the end effector Figure 1 A perspective view of a support plate of a support plate device.

[0016] Figure 7 yes Figure 1 A perspective view of a spreader device is shown manipulating the applicator assembly to couple the spreader to the end effector.

[0017] Figure 8 It is installed on the end effector Figure 1A perspective view of a brace of a brace arrangement showing perforations in the brace member.

[0018] Fig. 9 is a perspective view of a bracket for holding an instrument during installation of a strut assembly according to one embodiment.

[0019] Fig.10 yes Fig. 9 Front view of the bracket. DETAILED DESCRIPTION

[0020] Various non-limiting embodiments of the present invention will now be described to provide an overall understanding of the structure, function and principle of use of the devices, systems, methods and processes disclosed herein. One or more examples of these non-limiting embodiments are shown in the accompanying drawings. It will be understood by those of ordinary skill in the art that the systems and methods specifically described herein and shown in the accompanying drawings are non-limiting embodiments. Features shown or described in conjunction with one non-limiting embodiment can be combined with features of other non-limiting embodiments. Such modifications and variations are intended to be included within the scope of the present invention. References to "various embodiments", "some embodiments", "one embodiment", "some exemplary embodiments", "one exemplary embodiment" or "embodiments" throughout the specification mean that specific features, structures or characteristics described in conjunction with any embodiment are included in at least one embodiment. Therefore, the phrases "in various embodiments", "in some embodiments", "in one embodiment", "in some exemplary embodiments", "in one exemplary embodiment" or "in an embodiment" appearing throughout the specification do not necessarily all refer to the same embodiment. In addition, in one or more embodiments, specific features, structures or characteristics can be combined in any suitable manner.

[0021] During the suturing process, it may be advantageous to provide a support strut material through which the staples can be deployed. The strut or support material can help distribute the pressure of the multiple rows of staples to improve the grip of the staples in the tissue, or to maintain the integrity of the staple line. For example, a bioabsorbable material or biomaterial can be provided on the anvil surface and / or the staple cartridge surface, through which the staples can be deployed during use. This strut material holding the staples can then be cut with a blade or knife and the material can remain in the patient's body.

[0022] Embodiments of support struts for suturing devices used during laparoscopic surgery that may be inserted through a trocar are described herein. Laparoscopic surgery may include, for example, sleeve gastrectomy or gastrectomy, but is not limited to these procedures.

[0023] Reference Figure 1 and Figure 2In an exemplary embodiment, the stretcher device 10 includes a stretcher 12 removably coupled to an applicator assembly 14. The applicator assembly 14 is designed to carry the stretcher 12 and align the stretcher 12 on the end effector 16. The applicator assembly 14 can help to install the stretcher 12 on the first jaw 18 and the second jaw 20 of the end effector 16. The applicator assembly 14 can include an applicator body 22 and a release liner 24. The release liner 24 can include a stretcher fastener 26 releasably fastened to the release liner 24. The release liner 24 is configured to removably couple the stretcher 12 to the applicator body 22. The stretcher 12 can be positioned on the applicator body 22 (or positioned on an intermediate component such as an applicator base 28). Then, the release liner 24 can be positioned over the stretcher 12 so that the stretcher fastener 26 is fastened to the stretcher 12. The adhesive on the applicator body fixes the release liner 24 in place on a portion of the stretcher 12.

[0024] The applicator assembly 14 is designed to be inserted into and aligned with the jaws 18, 20 of the end effector 16. Once the applicator assembly 14 is aligned with the end effector 16, the jaws 18, 20 of the end effector can be clamped onto the brace 12. The release liner 24 can include a sacrificial sheet 30 that, when removed, exposes the brace fastener 26. In this configuration, the brace 12 is separated from the applicator assembly 14 and can be coupled to the end effector 16. The applicator assembly 14 or a separate tool is then used to wrap or press the brace 12 around the end effector 16 to attach the brace 12 to the end effector 16. For example, the applicator body 22 can be manipulated to press the brace fastener 26 against the end effector 16, thereby adhering the brace 12 to the end effector 16. The brace device 10 can be provided to the user with the brace 12 coupled to the applicator assembly 14, thereby allowing the end user to install the brace 12 on the end effector 16 when in use. Alternatively, the brace device 10 can be provided to the user in a state pre-installed on the end effector 16. During a surgical procedure, when the end effector 16 is clamped around tissue, the detachable portion 32 of the brace 12 can be released from the end effector 16, while the remaining portion 34 remains on the end effector 16. In order to allow the user to release the detachable portion 32 of the brace 12 from the end effector 16, the brace device 10 includes a mechanism such as a perforated band, a drawstring, etc. The detachable portion 32 of the brace 12 can be released from the end effector 16 before or after suturing adjacent tissues.

[0025] Still refer to Figure 1 and Figure 2, the brace assembly 10 may include more than one subassembly. The brace 12 may include one or more brace members 36. For example, the brace assembly 10 may include a first brace member 36a for the first jaw 18 of the end effector 16 (e.g., an anvil) and a second brace member 36b for the second jaw 20 of the end effector 16 (e.g., a staple cartridge). As used herein, terms such as "top" and "bottom" used to describe components of the brace assembly 10 are relative to the corresponding jaws of the end effector. For example, "top" may refer to the side of the component facing the corresponding jaw. Thus, for a brace to be applied to an anvil, the top surface of the brace may face the anvil face, while the bottom surface faces away from the anvil face. In the case where the brace 12 includes multiple brace members 36, the applicator assembly 14 may include an applicator subassembly 14a, 14b corresponding to each brace member 36a, 36b.

[0026] As described above, the brace 12 includes at least one brace member 36. Each brace member 36 may include a distal end 38, a proximal end 40, a first side 42, and a second side 44 opposite the first side. The brace member 36 may include a top surface 46 and a bottom surface 48. During surgery, the brace member 36 is sutured to the tissue. The brace member 36 may include a portion for remaining attached to the tissue after surgery and a portion that is removed with the end effector. For example, the brace member 36 may include a detachable portion 32 and one or more remaining portions 34. The remaining portion 34 may be coupled to the end effector 16 for the duration of the surgery, while the detachable portion 32 remains attached to the tissue after the surgery is completed. The detachable portion 32 can be removably coupled to the remaining portion 34. For example, the brace member 36 may include a series of perforations 50 separated by perforated bands 52 that removably couple the detachable portion 32 to the remaining portion 34. In one embodiment, the detachable portion 32 may be located between two remaining portions 34. For example, the brace member 36 may include a first remaining portion 34a coupled to a first side of the removable portion 32 and a second remaining portion 34b coupled to a second side of the removable portion 32 opposite the first side. In this configuration, the brace member 36 may include two sets of through holes 50 that couple the removable portion 32 to the first remaining portion 34a and the second remaining portion 34b.

[0027] The brace members 36 may be made of any suitable brace material, such as (permanent and bioabsorbable) polymers and biofilms. Exemplary materials for brace members include copolymers of polyglycolide (PGA) and trimethyl carbonate (TMC). Where the brace device 10 includes more than one brace member 36, these brace members 36 may be identical or different. For example, the brace device 10 may include different "anvil" and "stitch cartridge" brace members 36. Having identical brace members 36 will minimize the number of different components included in the brace 12. The brace members 36 may be symmetrical or asymmetrical (e.g., having different "top" and "bottom" sides). The brace members 36 may include proximal tabs to allow the brace members 36 to enter the proximal tissue stop of the end effector 16. Alternatively or additionally, the brace members may include distal tabs to enter the distal tissue stop of the end effector 16. The stretcher member 36 can span the length and at least the width of the end effector anvil plate in a single continuous member to capture each staple fired from the end effector 16. In some embodiments, the stretcher member 36 can include discrete adjacent segments that are combined together by the applicator assembly and that are longitudinally ( Figure 3 ) or transversely. Adjacent sections may also be "bridged" together so that the entire width of the brace member is not continuous. The brace member 36 may be positioned on one side of the cut line, depending on the procedure, as it may not be necessary to reinforce the sutures of the excised tissue. In some embodiments, the brace member 36 may include a slit 54 ( Figure 4 ) to initiate the cutting line. Slit 54 can be positioned adjacent to the cutting line. For example, slit 54 can be located at the center of the distal end of brace member 36. Slit 54 can be rectangular, triangular (bird's beak), etc. In one example, slit 54 can be segmented (e.g., to form a series of perforations), or can span the length of brace member 36, thereby eliminating the need to cut brace member 36 during surgery.

[0028] The size of the support plate 12 can vary depending on the intended application. The widths of the support plate members 36a, 36b can be the same or different. For example, the width of the anvil support plate member 36a is designed to wrap around the sides and / or top of the anvil, thereby providing sufficient contact with the end effector to properly adhere the support plate to the end effector. The distance that the support plate wraps around the two sides of the jaws can vary. In one embodiment, the anvil support plate is completely wrapped around the anvil, thereby maximizing the adhesion contact area. The support plate wrapping less than the entire jaw can improve the ability of the end effector to slide in the trocar. The width of the nail magazine support plate member 36b can be wider than the anvil support plate member 36a to compensate for the difference in width between the anvil jaws and the nail magazine jaws. In order to minimize the complexity of the parts and assemblies, the anvil and the nail magazine can use the same support plate. In various embodiments, the thickness can be in the range of, for example, about 0.1mm to about 0.5mm, about 0.2mm to about 0.3mm. The thickness can be about 0.26mm. The average density can be, for example, about 0.1g / cm 3 Up to about 1.7g / cm 3 , or about 0.25g / cm 3 to about 1.34g / cm 3 In various embodiments, the tensile stress of the support plate material can be in the range of about 700 psi to about 1300 psi, about 900 psi to about 1100 psi, or about 950 psi to about 1000 psi. The tensile stress can be, for example, about 983 psi.

[0029] The number and size of the perforations 50 and perforated strips 52 can vary. The perforated strips 52 are configured to have a relatively high burst strength and a relatively low tear strength. The relatively high burst strength helps prevent the perforated strips 52 from accidentally splitting when, for example, tissue is positioned between the jaws 18, 20 of the end effector 16. The relatively low tear strength increases the ease with which the removable portion 32 of the strut member 36 can be separated from the remainder 34 when the jaws 18, 20 of the end effector 16 are opened. The distal end of the line of perforations 50 can begin with the introduction of the perforations (e.g., the distal edge of the strut member 36 can be discontinuous).

[0030] The width and spacing of the perforated strip 52 can vary. The perforated strip 52 is configured to resist lateral loads during tissue manipulation and / or activation of the end effector. The width of the perforated strip 52 can be, for example, in the range of about 0.005 inches to about 0.1 inches, about 0.01 inches to about 0.05 inches, or about 0.01 inches to about 0.03 inches, or can be about 0.02 inches. The width of the perforations 50 (e.g., openings) can be, for example, in the range of about 0.01 inches to about 1 inches, about 0.1 inches to about 0.5 inches, or about 0.1 inches to about 0.3 inches, or can be about 0.24 inches. The ratio of the width of the perforations 50 to the width of the perforated strip 52 can be, for example, in the range of about 5 to about 20, or about 10 to about 15, or can be about 12. In one embodiment, the brace member 36 can include perforated strips 52 having different widths. For example, the stay member 36 may include an alternative perforated band 52 having a first width and a second width different from the first width.

[0031] The mechanical properties of the perforated belt 52, such as burst strength and tear strength, can vary. The burst strength (% hold) of the perforated belt 52 can be calculated based on the number of teeth per inch (the number of perforation teeth per inch that create "cuts" in the perforation pattern) multiplied by the belt width. In various embodiments, the burst strength (% hold) can be in the range of, for example, about 5% to 100%, about 5% to about 50%, about 5% to about 20%, about 5% to about 10%, or about 7% to 100%. The burst strength can be, for example, about 7.7%. In various embodiments, the number of teeth per inch (TPI) can be in the range of about 1 to about 10, about 1 to about 5, about 3 to about 4. The TPI can be, for example, about 3.4. The tear strength is a function of the belt width, the material thickness, and the maximum tensile stress of the material. The tear strength can be equal to the cross-sectional area (thickness multiplied by width) of the perforated belt 52 multiplied by the tensile stress of the brace material. In various embodiments, the perforation tear strength of a single perforated belt 52 can be in the range of greater than 0 to about 1 lb F, greater than 0 to about 0.5 lb F, about 0.1 lb F to about 0.3 lb F. The perforation tear strength can be, for example, about 0.197 lb F. The tear strength can vary depending on the perforated belt width, material thickness, and maximum material tensile stress.

[0032] Refer again Figure 1 and Figure 2, the applicator assembly 14 is used to apply the support plate 12 to the end effector 16. In one embodiment, the applicator assembly 14 may include an applicator body 22 and an applicator base 28. In the case where the applicator assembly 14 includes multiple subassemblies, each subassembly may include an applicator body 22 and an applicator base 28. The applicator assembly 14 can be disposable. In various embodiments, the applicator assembly 14 may include a pull tab. For example, when the support plate device includes more than one applicator subassembly, one or two of the applicator subassemblies may include a pull tab to facilitate separation of the applicator body. The pull tab may be, for example, rectangular or circular. The applicator body 22 may alternatively have a recess that allows the applicator body 22 to be more easily separated.

[0033] Each applicator body 22 can include a distal end 56, a proximal end 58, a first side 60, and a second side 62 opposite the first side. The applicator body 22 can include a top surface 64 and a bottom surface 66. The applicator body 22 can include lateral and longitudinal alignment features, such as cutouts 67, to ensure proper alignment when the brace device is mounted on the end effector 16. The applicator body 22 can be made of, for example, a flexible card material of any thickness, a stitched board, a particle board (such as SBS (solid bleached sulfite)), or any other semi-flexible member (such as semi-flexible foam, rubber, silicone or plastic). An exemplary material of the applicator body 22 can be polyester. The applicator body 22 can include an adhesive on a portion or all of the top surface 64. The adhesive can be, for example, an acrylic adhesive. The adhesive can be used to couple the release liner 24 to the applicator body 22. To further secure the release liner 24 in place, portions of the applicator body 22 can be folded over the edges of the release liner 24. For example, the outer edge 68 of the applicator body 22 can be folded over the top surface 64 of the applicator body 22 to form a folded portion 70. The folded portion 70 does not extend over the sacrificial sheet 30. In other words, the sacrificial sheet 30 remains uncovered. In the folded configuration, a portion of the bottom surface 66 of the applicator body 22 can be seen from the top of the applicator body 22. In one embodiment, the bottom surface 66 of the applicator body 22 is configured to include printed indicia, such as symbols or instructions. The indicia can be seen on the folded portion 70.

[0034] Still refer to Figure 2, each applicator base 28 can include a distal end 72, a proximal end 74, a first side 76, and a second side 78 opposite the first side. The applicator base 28 can include a top surface 80 and a bottom surface 82. The applicator base 28 can be made of any thin, flexible, hypoallergenic material and / or biocompatible material such as 4mil LDPE. An exemplary material of the applicator base 28 is polyester. The applicator base can provide additional strength to the applicator body 22. In one embodiment, the applicator base 28 spans the width and length of the support plate member 36. In the case where the applicator body 22 includes an adhesive, the applicator base 28 can cover a portion of the adhesive to prevent the support plate 12 from adhering to the applicator body 22. The adhesive on the side of the top surface 64 of the applicator body 22 can remain uncovered by the applicator base 28. The support plate member 36 can be positioned on the applicator base 28. In embodiments where the applicator assembly 14 does not include an applicator base 28, the portion of the applicator body 22 configured to contact the support plate member 36 can be free of adhesive. In some embodiments, one or more of the applicator substrate or the adhesive is discontinuous.

[0035] If the brace device 10 includes more than one applicator subassembly, the applicator subassemblies can be fastened together. In some embodiments, the applicator subassemblies can be fastened together in the area where the jaws of the end effector will clamp together. The applicator subassemblies can be fastened together by glue, tape, staples, sutures, etc.

[0036] Reference Figure 2 In various embodiments, the brace assembly 10 may include a flexible member 84 located between the applicator subassemblies. When the jaws 18, 20 are clamped, the brace members 36a, 36b and the applicator subassemblies 14a, 14b compress the flexible member 84, which helps to maintain the brace assembly 10 in a proper position between the jaws 18, 20. The flexible member 84 is designed to provide thickness to the area adjacent to the end effector 16 and enable the jaws 18, 20 of the end effector 16 to provide compression to the brace 12 during installation. The flexible member 84 can be adhered to the applicator body 22. In the case where the applicator assembly 14 includes multiple applicator subassemblies, the flexible member 84 can be adhered to each applicator body 22. The flexible member 84 can include an adhesive on the top surface 86 and the bottom surface 88, and can initially include a temporary pad to prevent accidental adhesion. The user can remove the temporary pad to adhere the flexible member 84 to the corresponding applicator body 22. In various embodiments, the flexible member 84 can be continuous along a region adjacent to the end effector 16, segmented longitudinally, or segmented laterally. The flexible member 84 can extend along the length of the applicator body 22, along the proximal portion, or along the distal portion. In one embodiment, the thickness of the flexible member 84 can taper, for example, longitudinally.

[0037] The flexible member 84 may include a distal end, a proximal end, a first side, and a second side opposite the first side. The flexible member may be made of foam, such as a cross-linked polyethylene foam (e.g., 2A) coated with an adhesive. ), or any other hypoallergenic flexible member, such as folded (fluted) particle board, rubber, or silicone. In one embodiment, the applicator bodies are each die cut bleached 0.009 inch card stock member, and the flexible member is a 3 / 32 inch thick, 3 / 8 inch wide foam strip. The compression may vary. For example, the foam compression at 25% deflection may be in the range of about 1 psi (pounds per square inch) to about 10 psi, or may be about 5 psi.

[0038] Reference Figure 1 , Figure 2 and Figure 5 In various embodiments, the release liner 24 is configured to temporarily couple the support plate 12 to the applicator body 22. Each release liner 24 can include a distal end 90, a proximal end 92, a first side 94, and a second side 96 opposite the first side. The release liner 24 can include a top surface 98 and a bottom surface 100. The release liner 24 can include a side portion 102 and a sacrificial sheet 30, the side portion 102 being configured to be coupled to the applicator body 22 as described above, and the sacrificial sheet 30 being removably fastened to the side portion 102 via perforations 103. The side portion 102 can include alternating protrusions 104 and recesses 106. For purposes of illustration, in Figure 2, the protrusion 104 and the recess 106 are shown only on one side of the top release liner 24, but the technology is not limited thereto. When the edge of the applicator body 22 is folded over the side 102 of the release liner 24, the recess 106 allows the following areas: in these areas, the applicator body 22 adheres to itself when the applicator body 22 adheres to the protrusion 104 of the release liner 24. The release liner 24 can also include a removable center portion 108, which is removably fastened to the sacrificial sheet 30 (e.g., by perforations). After the support plate device 10 is assembled and before it is positioned on the end effector 16, the removable center portion 108 can be removed to expose a portion of the support plate 12. The side 102, the sacrificial sheet 30, and the removable center portion 108 can be releasably connected (e.g., sewn together) using features other than perforations. The sacrificial sheets 30 can each include a grip 110. For example, the sacrificial sheet 30 may include a longitudinal portion 112 extending along the length of the brace device 10 and an extension portion 114 extending transversely from the longitudinal portion 112. The extension portion 114 may be folded over on itself to provide additional strength. The gripping portion 110 may be located at the end of the extension portion 114. The gripping portions 110 of adjacent sacrificial sheets 30 may be coupled. For example, the gripping portions 110 may be adhered together, for example, using an adhesive sheet. The gripping portion 110 may be shaped to provide a directional indication of how the gripping portion 110 should be pulled to remove the sacrificial sheet 30 from the brace device 10. For example, the gripping portion 110 may be shaped as an arrow. In an embodiment where the top surface 98 of the release liner 24 does not include a release coating, the adhesive sheet may provide better adhesion to the folded gripping portion 110 than the adhesion provided to the bottom surface 100 of the release liner 24 by the brace fastener 26.

[0039] Release liner 24 can be made of, for example, kraft paper or plastic (e.g., polyester). Release liner 24 can include a release coating, such as a silicone release coating or a fluorosilicone release coating. The release coating can be on one or both sides of release liner 24. The release coating can be continuous or discontinuous. During assembly of the stretcher device 10, stretcher fastener 26 can be releasably adhered to release liner 24. In one example, stretcher fastener 26 is removably adhered to the side of release liner 24 that includes the release coating.

[0040] Still refer to Figure 2 As described above, the stay plate 12 can be attached to the end effector by the stay plate fastener 26. The stay plate fastener 26 ensures that the stay plate 12 is taut and aligned relative to the lateral and longitudinal alignment features on the applicator assembly 14. In some embodiments, the stay plate fastener 26 can be a medical grade transfer adhesive. In other embodiments, the stay plate fastener 26 can include a high-tack, hypoallergenic double-sided tape (e.g., 3M TMMedical tape 1567), single-sided tape, cyanoacrylate and other glues, staples, etc. Exemplary medical grade transfer adhesives are synthetic rubber-based adhesives, such as 1504XL high-tack medical transfer adhesive from 3M, or acrylic adhesives. The support plate fastener 26 may include discrete sections. For example, the support plate fastener 26 may include two longitudinal adhesive strips. As described above, the top of the support plate fastener 26 can be releasably adhered to the release liner 24, which is used to position the support plate fastener 26 on the support plate 12 during assembly of the support plate device 10. The temporary liner can be removed from the bottom of the support plate fastener 26 opposite the release liner 24, and then the temporary liner can be positioned on the support plate 12. The temporary liner can prevent the support plate fastener 26 from accidentally adhering to something other than the support plate 12.

[0041] In various embodiments, the brace fastener 26 can be continuous along the length of the brace 12 to maximize adhesion, wherein the brace fastener 26 is segmented longitudinally or transversely. The brace fastener may alternatively not include an adhesive and may include a row of staples, rivets, tacks, etc. to secure the brace to the applicator. The brace fastener 26 is designed to secure the brace 12 to the end effector 16, but also provide a fastening force to the end effector that is greater than the force to tear the perforations, as discussed herein. In addition, the properties of the release liner 24 and the adhesion of the brace fastener 26 are designed so that the brace fastener 26 will not delaminate from the brace 12 when the release liner 24 is removed. Because the jaws 18, 20 of the end effector 16 can have a non-stick coating (e.g., PTFE), the brace fastener 26 is configured to have a sufficiently strong adhesive to retain the remaining portion 34 of the brace on the end effector 16 when the perforated tape 52 is torn. By using higher surface energy substrates, etc., the 90° peel force of the adhesive to the jaws 18, 20 of the end effector 16 ("peel force") can be varied by varying the surface area over which the spreader fastener 26 extends. In various embodiments, the peel force can be in the range of about 0.1 lbF to about 5 lbF, about 0.5 lbF to about 5 lbF, about 0.5 lbF to about 3 lbF, about 0.6 lbF to about 5 lbF, or about 0.6 lbF to about 2 lbF, or can be about 0.6 lbF. In one embodiment, the minimum 90° peel force of the spreader fastener 26 to the jaws 18, 20 of the end effector 16 is greater than the tear strength of the perforated tape 52.

[0042] To assemble the brace assembly 10, a temporary pad ( Figure 2) is removed from the applicator body 22 to expose the adhesive. If an applicator base 28 is being used, it can be positioned above the applicator body 22. The support plate 12 can then be positioned on the applicator base 28 (or the applicator body 22). The temporary liner can be removed from the support plate fastener 26, and the release liner 24 can be positioned on the support plate member 36, wherein the support plate fastener 26 faces the top surface 46 of the support plate member 36. The outer edge 68 of the applicator body 22 can be folded over the side 102 of the release liner 24. If the release liner 24 extends completely over the support plate 12, the removable center portion 108 can be removed to expose a portion of the support plate 12. The sacrificial sheet 30 is maintained in place on the support plate fastener 26. The extension portion 114 of the sacrificial sheet 30 can be folded, and adjacent grips 110 can be adhered to each other. Multiple support plates and applicator subassemblies can be made in the same manner. If a flexible member 84 is used, it can be coupled to one or more applicator bodies 22. To this end, the temporary liner may be removed from the flexible member 84 to adhere it to the applicator body 22 .

[0043] Various components may include features that are used during assembly but removed prior to application. For example, the applicator body, applicator base, stays, and release liner may include a perforated sheet. During assembly, the perforations on the perforated sheet may be positioned over alignment features (e.g., dowel rods). This helps ensure that the components are properly positioned. After assembly, the perforated sheet may be removed.

[0044] To apply the spreader 12 to the end effector 16, the spreader assembly 10 is inserted between the jaws 18, 20. When the spreader assembly 10 is positioned in the end effector 16, as shown in FIG. Figure 5 As shown, the brace 12 can be separated from the applicator assembly 14. To remove the sacrificial sheet 30, the user grasps the gripping portion 110 of the sacrificial sheet 30 and pulls it along the length of the brace device 10 to tear the perforations and expose the brace fasteners 26. At this point, the brace 12 is positioned on the applicator assembly 14, but not coupled to the applicator assembly 14. The top of the brace 12 can be completely exposed. The brace 12 can be fastened to the end effector 16 by bending the sides of the applicator assembly 14 around the jaws to adhere the brace fasteners 26 to the jaws 18, 20. Figure 6 The strut plate 12 is shown adhered to the end effector 16 .

[0045] The perforations 103 may span the length of the release liner 24 and cut through the end of the release liner 24, providing a "start" or introduction perforation to ensure the reliability of the mechanism. The sacrificial sheet 30 may be designed to be pulled both laterally and proximally, as indicated by the directional arrow-shaped grips 110. This will help ensure that the perforations 103 tear and the release liner 24 peels away from the brace fastener 26. As an alternative to the user pulling on multiple grips 110 on each side of the brace device 10, the upper grips 110 and lower grips 110 may be fastened together so as to separate with one pulling motion. Other mechanisms may be used to release the brace from the applicator assembly, such as chain stitches, release liners (which can be found on consumer foam mounting tapes, such as Command & Conquer foam mounting tapes, etc.) TM Article) etc.

[0046] After the sacrificial sheet 30 of the release liner 24 is separated from the brace 12, the brace 12 can be coupled to the end effector. The techniques used to couple the brace to the end effector can vary. As described above, the brace fasteners 26 can adhere the brace to the end effector. As another example, the brace can be coupled to the jaws by bonding with tape, glue, etc. or by mechanical fastening (e.g., tying, clamping, etc.). Figure 7 , the applicator assembly 14 can be used to couple the stay 12 to the end effector 16. The sides of the applicator assembly 14 can be folded upward around the jaws 18, 20 to press the stay fastener 26 against the jaws 18, 20.

[0047] During a procedure, a user may separate the removable portion of the brace member from the end effector so that the removed portion remains attached to the tissue. As described above, the brace member may include perforations that tear to separate the removable portion of the brace member from the end effector. The perforations in the brace member may be separated by a variety of techniques. Figure 2 and Figure 8 In the example shown, the brace member 36 includes perforations 50 along its length. In one embodiment, the perforations 50 can be positioned so that when the brace member 36 is coupled to the jaws 18, 20, the perforations 50 are positioned on one side of the jaws 18, 20. Opening the jaws 18, 20 of the end effector 16 will cause the perforations 50 to tear. In some embodiments, the brace device 10 can include a mechanism by which a user can selectively tear the perforations 50. One example includes a suture wrapped around the perforations 50. In use, one end of the suture extends outside the patient's body. The user can pull the suture from outside the patient's body so that the suture cuts the perforations 50. In another example, two sets of perforations 50 are separated by a tab, and the suture is coupled to the end of the tab. Pulling the suture will cause the tab to tear from the brace member 36. Components other than sutures can be used to selectively tear the perforations 50. For example, during surgery, the end of the tab can extend outside the patient's body and can be pulled away from the brace member 36.

[0048] In one embodiment, a method for suturing a patient's anatomical structure during minimally invasive surgery may include providing an end effector, wherein the anatomical structure has a first side and a second side. The end effector may include: a first jaw having a first end, a second end, a longitudinal axis, and an anvil, wherein the anvil includes an anvil face; a second jaw having a first end, a second end, a longitudinal axis, and a staple cartridge holding a plurality of staples, wherein the staple cartridge has a staple cartridge face. The first end of the first jaw may be coupled to the first end of the second jaw, and the second end of the first jaw may be coupled to the second end of the second jaw. The end effector may also include: a support plate, the support plate including a detachable portion and a remaining portion, wherein the detachable portion and the remaining portion are removably coupled by a perforated band, and the remaining portion is coupled to the first jaw or the second jaw for the duration of the minimally invasive surgery; and a knife coupled to the first jaw or the first jaw and capable of sliding relative to the first jaw or the first jaw. The method may include inserting an end effector through a trocar to access an anatomical structure, positioning a staple cartridge face on a first side of the anatomical structure, positioning an anvil face on a second side of the anatomical structure, clamping the end effector on the anatomical structure, operating the end effector to cause the plurality of staples from the staple cartridge to suture the anatomical structure, actuating the knife to cut the anatomical structure, and opening the end effector to tear the perforated band. The end effector may then be removed from the trocar so that the detachable portion remains sutured to the anatomical structure while the remaining portion remains attached to the end effector.

[0049] In the event that the end user mounts the strut assembly on the end effector, an exemplary embodiment includes a bracket that aids in mounting by holding the end effector upright, stabilizing it, and allowing it to be opened and closed. Fig. 9 and Fig.10 A suturing device 150 is shown that includes an end effector 16 positioned on a bracket 152. The bracket can be reusable and made of a material that can withstand repeated sterilization processes. For example, the bracket can be made of a metal such as stainless steel, or made of a sterilizable or autoclavable plastic. The bracket can be disposable, such as a thermoformed bracket, and can be incorporated into a device tray that is already mounted on the device. Fig. 9As shown, the tip of the end effector 16 can be placed on the same plane (e.g., a tabletop) as the placement bracket 152. In other embodiments, the bracket can hold the end effector horizontal or tilted, such as at 90 degrees. In one embodiment, the bracket can include two separate parts: one portion constrains the handle of the device and the other portion constrains the tip of the end effector. In one embodiment, the width of the applicator body can be determined based on the bracket. For example, when the spreader device is inserted between the jaws while the suturing device 150 is positioned on the bracket, the size of the applicator body can be set so that the applicator body does not contact the surface when the spreader is pressed against the lower jaw.

[0050] In various embodiments, the applicator may include a label, such as instructions. Installation errors may be mitigated by using instructions printed on the applicator to remind the user of the correct technique and sequence of operations for installing the stays on the end effector. The instructions may be incorporated into the applicator by printing, stickers, etc. The instructions may use a warning font, color, custom or universal action symbols, or any font, color, or symbol to inform the user. For example, the label may be included on the folding surface of the top applicator body. In one embodiment, the sequential numbering scheme depicts the sequence of operations with large red text. Each step has medium text in black to communicate to the user the technique for the current step. The custom symbol for the end effector will orient the applicator in the yaw direction. The custom symbol for the film pull tab communicates to the user the feature to pull. Once the top of the top applicator body is folded up, the exemplary label on the top of the bottom applicator body is peeled off. The sequential numbering and instruction step scheme continues. The universal "pinch" symbol instructs the user to pinch the applicator assembly. The universal "wrap" symbol accompanies the instruction step, instructing the user to wrap the applicator around the jaws of the end effector. If the applicator assembly is inverted, a warning may appear to the user, for example in yellow with extra large text.

[0051] In one embodiment, the riser may include a riser-base film assembly. The riser member may be removably secured to the base film member. The means for securing the riser member to the base film member may be any seam that can arbitrarily separate these members, a peel line for separating adhesive, or a liner (as found on consumer foam mounting tapes, such as Command & Conquer). TMStrips), perforation mechanisms, wherein perforations are cut in the film - for example, the mechanism proposed above to separate the sutured brace portion from the applicator, or perforations are cut in the brace member. The mechanism can allow the user to arbitrarily separate the brace member from the end effector, for example, by providing a tail that is pulled from outside the patient's body, or by incorporating the mechanism into the end effector, the brace member can be separated from the end effector. The brace member can be manually or automatically separated from the end effector from outside the patient's body by direct action of the user or from the inside by a mechanism on the end effector. For example, the knife / firing mechanism (or other closed system) can be configured to automatically separate the brace member from the end effector. In one embodiment, the applicator base of the applicator assembly can be configured to be attached to the end effector. In various embodiments, the base film member can be attached to the end effector by a separate fastening component (such as a single-sided tape, a double-sided tape, a transfer adhesive, a glue such as a cyanoacrylate, etc.).

[0052] In embodiments where the brace member has portions sewn together, the sutures can be untied to release the sewn portions of the brace member from the end effector. The brace fasteners used to connect the brace to the end effector can also temporarily secure the tail of the suture. As described above, when the tail end of the suture is secured, the suture provides a secure fastening. During assembly, transportation, and installation, it may be desirable to prevent the sutures on the brace from unraveling. During use, untying the sutures can provide easy, reliable, and controlled release of the brace member from the patient's body and the end effector. To achieve these two functions, the tail end of the suture can be temporarily secured in place by a brace fastener (or a separate component). For example, the distal and proximal ends of the suture can be secured by a brace fastener. The ends of the sutures can be temporarily secured using components other than brace fasteners. For example, a knot or bead can be included on a suture or line pulled through a brace or applicator base. Another method of terminating the line is to adhere a double-sided tape member to the length of the line. This approach adheres the stay assembly to the end effector, secures the ends of the wire by capturing them in double-sided tape, and increases the force required to pull the suture. It will be appreciated that other techniques for ensuring the integrity of the assembly and preventing accidental activation of the release mechanism may be used. In one embodiment, to separate the stay member from the applicator base, the tail end of the suture may be released from the stay fastener and pulled.

[0053] In one embodiment, the applicator assembly can be designed to fold from a planar configuration to a three-dimensional configuration to assist in mounting the brace plate on the jaws of the end effector. For example, the sides of the applicator assembly are pinched to fold the applicator, thereby forming a wall that adheres the double-sided tape of the brace plate to the jaws of the end effector. The applicator body can be a static die-cut component that aligns the brace plate with the end effector when the brace plate is adhered to the jaws of the end effector by a separate mechanism (such as a tool that slides along the jaws of the end effector) or by a sacrificial "handle" on the applicator base (which the user can manipulate and wrap the brace plate around the jaws of the end effector). After the brace plate is secured to the end effector, the handle can be torn off and discarded by perforating the hole, etc.

[0054] In various embodiments disclosed herein, a single component may be replaced by multiple components, and multiple components may be replaced by a single component to perform a given function or functions. Unless such a replacement does not work, such a replacement falls within the intended scope of the embodiment.

[0055] The above description of embodiments and examples is given for the purpose of illustration and description. It is not intended to be exhaustive or to limit the forms described. In view of the above teachings, many modifications are possible. Some of these modifications have been discussed, and other modifications will be understood by those skilled in the art. These embodiments are selected and described in order to best illustrate the principles of various embodiments suitable for the intended specific use. Of course, the scope is not limited to the examples illustrated herein, but those of ordinary skill in the art may use them in any number of applications and equivalent devices. On the contrary, the scope of the present invention is intended to be limited by the appended claims.

Claims

1. A support plate device, comprising: An applicator assembly, the applicator assembly comprising: an applicator body that is flexible; and a release liner comprising a sacrificial sheet; wherein the release liner is coupled to the applicator body; and a riser positioned on the applicator body; and a strut fastener configured to couple the strut to an end effector, wherein the strut fastener is configured to releasably fasten to the release liner; The stretcher device has a first configuration and a second configuration, wherein in the first configuration, the stretcher is coupled to the applicator assembly and in the second configuration, the stretcher is separated from the applicator assembly, wherein in the second configuration, the sacrificial sheet is separated from the release liner, wherein the sacrificial sheet is removably fastened to a side of the release liner via a perforation, wherein the sacrificial sheet includes a longitudinal portion, an extension portion extending laterally from the longitudinal portion, and a grip at an end of the extension portion.

2. The support plate device according to claim 1, wherein: The brace plate includes a removable portion and a remaining portion, the removable portion and the remaining portion being coupled by a perforated band, wherein the perforated band separates perforations in the brace plate.

3. The support plate device according to claim 2, wherein: The tear strength of the perforated tape is less than the peel force of the strut fastener on the end effector.

4. The support plate device according to claim 3, wherein: The tear strength of the single perforated belt is in the range of greater than 0 to 1 lbF.

5. The support plate device according to claim 3, wherein: The peel force is in the range of 0.1 lbF to 5 lbF.

6. The support plate device according to claim 2, wherein: The riser fastener is coupled to the remaining portion of the riser.

7. The support plate device according to claim 1, wherein: The stay plate fastener includes an adhesive.

8. The support plate device according to claim 1, wherein: The riser includes longitudinally separated discrete segments.

9. The support plate device according to claim 1, wherein: The applicator assembly also includes an applicator base, wherein in the first configuration, the applicator base is positioned between the applicator body and the riser.

10. The support plate device according to claim 1, wherein: The applicator body has an adhesive top surface coupling the release liner to the applicator body.

11. The support plate device according to claim 1, wherein: The edges of the applicator body are folded over the sides of the release liner.

12. The support plate device according to claim 11, wherein: The sides of the release liner include alternating protrusions and recesses, wherein the edges of the applicator body are folded over the alternating protrusions and recesses.

13. The support plate device according to claim 1, wherein: The first surface of the release liner includes a release coating.

14. The support plate device according to claim 11, wherein: The extension portion is folded upon itself.

15. The support plate device according to claim 1, wherein: The applicator assembly is a first applicator assembly, and the spreader device further includes a second applicator assembly and a flexible member coupled to the first applicator assembly and the second applicator assembly.

16. The support plate device according to claim 1, wherein: The riser device has a third configuration, wherein in the third configuration the riser is removed from the applicator assembly.

17. A surgical suturing system, comprising: The support plate device according to claim 1; as well as A surgical stapler includes the end effector having a first jaw and a second jaw, wherein the spreader device is inserted through the first jaw and the second jaw.

18. A method of assembling the brace assembly according to claim 1, the method comprising: positioning the riser on the applicator body; as well as The release liner is positioned on the riser to adhere the riser fastener to the riser, wherein the release liner is coupled to the applicator body.

19. The method of claim 18, further comprising folding edges of the applicator body over sides of the release liner.

20. The method according to claim 18, wherein: The applicator assembly is the first applicator assembly and the spreader device further includes the second applicator assembly and the flexible member, the method further comprising coupling the flexible member to the first applicator assembly and the second applicator assembly.

21. The method of claim 18, further comprising removing a temporary liner initially positioned on the riser fastener from the riser fastener prior to positioning the release liner on the riser.

22. The method of claim 18, further comprising removing a temporary liner initially positioned on the applicator body from the applicator body to expose the adhesive top surface of the applicator body.

23. The method of claim 18, further comprising positioning the applicator base on the applicator body, and wherein: Positioning the riser plate on the applicator body includes positioning the riser plate on the applicator base.

24. A method of applying a support plate to an end effector, the method comprising: A support plate device is installed on the end effector, and the support plate device includes: An applicator assembly, the applicator assembly comprising: an applicator body that is flexible; and a release liner comprising a sacrificial sheet; wherein the release liner is coupled to the applicator body; the riser positioned on the applicator body; and a stay plate fastener, wherein the stay plate fastener is coupled to the stay plate and releasably fastened to the sacrificial sheet of the release liner; separating the release liner from the sacrificial sheet to expose the stay fastener; and manipulating the applicator body to adhere the stay fastener to the end effector, Wherein, the sacrificial sheet is removably fastened to the side of the release liner through perforations Wherein, the sacrificial sheet includes a longitudinal portion, an extension portion extending laterally from the longitudinal portion, and a grip portion at an end of the extension portion.

25. The method of claim 24, further comprising removing the applicator assembly from the end effector.

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